MAUDE Adverse Event Report: SMITH & NEPHEW, INC. EVOS 3.5MM P/A PM-P TIB I-PL 5H R 78MM; PLATE, FIXATION, BONE

Model Number	72453605
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery, the plate holes of the evos 3.5mm p/a pm-p tib i-pl 5h r 78mm were damaged during drilling, and the screw went through the plate, hence the placement of the plate was positioned wrongly upon checking the xray.The procedure was completed using an s+n back-up device.There was a non significant delay.No further information is available.
Additional Manufacturer Narrative
H10: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.Three of the device's holes were found to be damaged, rendering the device inoperative.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that the four provided fluoroscopic images were reviewed.The visual inspection confirmed three holes of the device were damaged.However, the images and visual inspection do not aid in the clinical investigation of the root cause of the reported damaged plate holes or assess the impact to the patient.Based on the limited information provided, we are unable to rule out a user vs procedural variance as a contributing factor as the likely cause of the reported event.Per the complaint details, the procedure was completed using a s+n back-up device with a non-significant delay.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage.Some potential probable causes for this event could include a fit/ sizing issue or poor insertion technique.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.Internal complaint reference number: (b)(4).

• Brand Name: EVOS 3.5MM P/A PM-P TIB I-PL 5H R 78MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; austin, TX 78735 ; 5123913905
• MDR Report Key: 14402935
• Report Number: 1020279-2022-02364
• Device Sequence Number: 5552321
• Product Code: HRS
• UDI-Device Identifier: 00885556640814
• UDI-Public: 00885556640814
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K170457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 72453605
• Device Catalogue Number: 72453605
• Device Lot Number: 19JM07200
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown